BEUDAMED
    FDA Enforcement Class II Terminated

    NuOSS Cancellous Intended for use in dental surgery.

    Recall: Z-1096-2016 · Reported March 23, 2016

    Enforcement

    Recall Number
    Z-1096-2016
    Event ID
    73222
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Collagen Matrix Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 23, 2016
    Initiation Date
    August 25, 2015
    Classification Date
    March 11, 2016
    Termination Date
    May 11, 2016
    Address
    509 Commerce St, Franklin Lakes, NJ, 07417-1374, United States

    Description

    NuOSS Cancellous Intended for use in dental surgery.

    Reason

    On 8/25/2015, Collagen Matrix, Inc discovered that one of the 171 units of NuOss Cancellous product shipped to a distributor may have included an incorrect size.

    Code Info

    Reference No. BM2C20010-U Lot no. BM2CU15E2

    Distribution

    US Distribution to the state of : MA

    Quantity

    171 units